Serán BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee and provide strategic and operational leadership for the organization’s validation, qualification, and computerized systems assurance programs. This role will support GMP manufacturing, laboratory, and quality systems that stretch across clinical and commercial operations.
This position is responsible for establishing and maintaining a risk-based validation and CSA framework ensuring that facilities, utilities, equipment, analytical methods, processes, and computerized systems remain in a validated state throughout their lifecycle. The Director, Quality Engineering & CSA ensures all validation and data integrity activities comply with FDA, EU, and international regulatory requirements, including cGMP, GAMP guidance, and current regulatory expectations for data integrity.
The role partners with Engineering, Manufacturing, Quality Control, IT, Regulatory Affairs, and Technical Operations to ensure validated systems and processes enable safe, compliant, and reliable manufacturing of clinical and commercial products. The Director, Quality Engineering & CSA also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to validation lifecycle management, computerized system assurance, and data governance.
Duties and Responsibilities
Strategic Leadership
Develops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programs
Supports the establishment governance structures for risk-based validation lifecycle management including planning, execution, maintenance, and periodic review
Leads initiatives to modernize validation practices including CSA adoption, digital validation approaches, and automation lifecycle management
Defines key performance indicators (KPIs) and metrics to measure effectiveness of QualityEngineering and CSA programs
Provides leadership to cross-functional teams supporting validation, qualification, and system lifecycle activitie
Validation Lifecycle Oversight
Provides Quality leadership and oversight of validation programs including:
Facility, utility, and equipment qualification, Cleaning validation, Computerized systems validation / assurance, & Manufacturing automation systems
Key activities include:
Approval and oversight of validation lifecycle documentation including:
Validation Master Plans (VMP), User Requirement Specifications (URS), Functional and Design Specifications, Risk assessments, IQ/OQ/PQ protocols and reports, & Validation summary reports
Ensures validation activities comply with internal procedures and regulatory requirements and remain aligned with the site Validation Master Plan
Provides quality oversight for commissioning, qualification, and validation activities in highly automated manufacturing environments
Ensures validated systems maintain a continuous state of control throughout their operational lifecycle
Computer System Assurance (CSA) & Data Integrity
Supports the design and implementation of the organization’s Computer System Assurance (CSA) and Computerized System Validation (CSV) programs
Ensures computerized systems comply with data integrity principles (ALCOA++) and regulatory expectations
Oversees validation lifecycle management for computerized systems including:
Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality management systems, Electronic Batch Record Systems, & Enterprise resource planning systems
Implements risk-based testing approaches consistent with GAMP 5 and modern CSA methodologies
Leads initiatives to strengthen enterprise data integrity governance programs across manufacturing, laboratory, and quality systems
Supports system lifecycle activities including system upgrades, migrations, and decommissioning
Operational Quality Engineering Support
Provides QA oversight and approval for quality system elements impacting validated systems including:
Change control processes impacting validated systems and processes, Deviation and investigation management, Corrective and Preventive Actions (CAPA), Risk management and impact assessments, & Periodic reviews of validated systems
Ensures that validation and CSA programs remain aligned with corporate policies, regulatory guidance, and evolving industry standards
Provides QA support for technology transfer, new product introductions, and site capital projects
Serves as the Quality Engineering representative for site project teams implementing new equipment, systems, or manufacturing technologies
Supports troubleshooting of complex process or system issues impacting validated systems
Serve as subject matter expert for validation, computerized systems assurance, and data integrity during regulatory inspections and Client audits
Leads preparation and inspection readiness programs related to validation and data integrity
Leadership & People Management
Leads and develops a high-performing Quality Engineering and CSA organization
Provides mentoring, coaching, and professional development for technical staff
Establish clear departmental goals aligned with organizational quality and operational objectives
Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications
Fosters a culture of quality ownership, compliance, and continuous improvement
Required Knowledge and Skills
Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
Experience organizing and managing work responsibilities while working independently with minimal oversight
Deep expertise in Computer System Validation / Computer System Assurance
Validation lifecycle management, Data integrity regulations and industry guidance, Risk-based validation methodologies
Time and project management skills with the ability to multi-task and meet deadlines
Excellent verbal and written communication skills
Excellent interpersonal and customer service skills
Excellent organizational skills and attention to detail
Strong analytical and problem-solving skills
Strong supervisory and leadership skills
Ability to prioritize tasks and to delegate them when appropriate
Willingness to accept feedback from a variety of sources
Ability to constructively manage conflict
Ability to collaborate and work in cross-functional teams
Ability to function well in a high-paced and at times stressful environment
Ability to maintain productive relationships with coworkers, clients, and other contacts outside the company
Proficient with Microsoft Office Suite or related software
Education and Experience
Bachelor’s degree, preferably in a scientific discipline. Preference will be given to those with an advanced degree
Minimum of 10+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry
Minimum of 5+ years previous experience with qualification/validation/CSA activities in a QA or Technical capacity
Demonstrated experience with regulatory inspections by the FDA and EU authorities
Physical Requirements
Prolonged periods of sitting or standing at a desk and working on a computer
Must be able to lift up to 15 pounds at times
Adheres to consistent and predictable in-person attendance
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
